Neuroendocrine Neoplasm of LungNCT06282016
Risk Factors for Neuroendocrine Neoplasms
An observational study of Neuroendocrine Neoplasm of Lung and Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder), run by Bavarian Cancer Registry at 1 site in Germany.
Trial summary
Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Neoplasm of Lung, Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
- How many people
- 14,250 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cases are defined as all persons with a malignant neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023. Controls are defined as noncases in the source population of cases, i.e. persons with a statutory health insurance and at least one outpatient physician contact in Bavaria between 2021 and 2023, whose residence was in Bavaria. Two controls will be sampled for each case.
Who may be able to join
- Persons with a statutory health insurance (about 85% of the population) and at least one outpatient physician contact in Bavaria between 2021 and 2023
- Residence in Bavaria
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacqueline Müller-Nordhorn contact
Germany1 site, 1 recruiting
- Recruiting
Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
Nuremberg, Bavaria, 90441
Martin Meyer, Dr., +49 (0)9131 6808-2920, martin.meyer@lgl.bayern.de
About this study
Official title: Risk Factors for Neuroendocrine Neoplasms: a Case-control Study Based on a Record Linkage of Registry and Claims Data
Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors.
- Conditions
- Neuroendocrine Neoplasm of Lung, Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
- Being tested
- Case-control study (no intervention)
- Keywords
- Neuroendocrine neoplasms, Colorectal cancer, Risk factors, Case-Control Study, Cancer Registry
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-control study (no intervention)Other
Observation of risk factors in cases and controls
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023 Receives: Other: Case-control study (no intervention) | |
| Controls | Patients without a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023 (=no documented diagnosis of neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system in the Bavarian Cancer Registry) Receives: Other: Case-control study (no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assured NEN diagnosis of the BPS
Neuroendocrine neoplasm of the bronchopulmonary system
Measured: 2021-2023
Assured NEN diagnosis of the GEPS
Neuroendocrine neoplasm of the gastroenteropancreatic system
Measured: 2021-2023
Secondary outcomes (4)
Assured NET diagnosis of the BPS
Neuroendocrine tumour of the bronchopulmonary system
Measured: 2021-2023
Assured NEC diagnosis of the BPS
Neuroendocrine carcinoma of the bronchopulmonary system
Measured: 2021-2023
Assured NET diagnosis of the GEPS
Neuroendocrine tumour of the gastroenteropancreatic system
Measured: 2021-2023
Assured NEC diagnosis of the GEPS
Neuroendocrine carcinoma of the gastroenteropancreatic system
Measured: 2021-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 May 2025
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine Neoplasm of LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 14,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bavarian Cancer Registry
- Sponsor type
- Other government
- Collaborators
- Bavarian Association of Statutory Health Insurance Accredited Physicians
- Responsible party
- Sponsor
- Investigators
- Jacqueline Müller-Nordhorn, Principal investigator, Bavarian Cancer Registry, Bavarian Health and Food Safety AuthorityMartin Tauscher, Principal investigator, Bavarian Association of Statutory Health Insurance Accredited Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282016
- Sponsor's protocol ID
- BKR-2024-001
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voigtlander S, Gerlach R, Grundmann N, Donnachie E, Berger U, Hakimhashemi A, Meyer M, Tauscher M, Muller-Nordhorn J. Risk factors for neuroendocrine neoplasms: protocol for a case-control study based on a record linkage of registry and claims data. BMJ Open. 2025 May 23;15(5):e096273. doi: 10.1136/bmjopen-2024-096273.
PubMed 40409959
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Neuroendocrine Neoplasms: a Case-control Study Based on a Record Linkage of Registry and Claims Data
- ClinicalTrials.gov ID
- NCT06282016
- Acronym / sponsor ID
- BKR-2024-001
- Conditions
- Neuroendocrine Neoplasm of Lung, Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
- Keywords
- Neuroendocrine neoplasms, Colorectal cancer, Risk factors, Case-Control Study, Cancer Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 14,250 participants (estimated)
- Lead sponsor
- Bavarian Cancer RegistryOther government
- Collaborators
- Bavarian Association of Statutory Health Insurance Accredited Physicians
- Study start
- 15 May 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Case-control study (no intervention)Patients with a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023 |
| Controls | – | Other: Case-control study (no intervention)Patients without a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023 (=no documented diagnosis of neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system in the Bavarian Cancer Registry) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases are defined as all persons with a malignant neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023. Controls are defined as noncases in the source population of cases, i.e. persons with a statutory health insurance and at least one outpatient physician contact in Bavaria between 2021 and 2023, whose residence was in Bavaria. Two controls will be sampled for each case.
Key inclusion criteria (2 listed)
- Persons with a statutory health insurance (about 85% of the population) and at least one outpatient physician contact in Bavaria between 2021 and 2023
- Residence in Bavaria
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case-control study (no intervention)Observation of risk factors in cases and controls | Other | Cases, Controls |
Primary outcome
Assured NEN diagnosis of the BPS
Time frame: 2021-2023
Neuroendocrine neoplasm of the bronchopulmonary system
Assured NEN diagnosis of the GEPS
Time frame: 2021-2023
Neuroendocrine neoplasm of the gastroenteropancreatic system
4 secondary outcomes
Assured NET diagnosis of the BPS
Time frame: 2021-2023
Assured NEC diagnosis of the BPS
Time frame: 2021-2023
Assured NET diagnosis of the GEPS
Time frame: 2021-2023
Assured NEC diagnosis of the GEPS
Time frame: 2021-2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 40409959Voigtlander S, Gerlach R, Grundmann N, Donnachie E, Berger U, Hakimhashemi A, Meyer M, Tauscher M, Muller-Nordhorn J. Risk factors for neuroendocrine neoplasms: protocol for a case-control study based on a record linkage of registry and claims data. BMJ Open. 2025 May 23;15(5):e096273. doi: 10.1136/bmjopen-2024-096273.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacqueline Müller-Nordhorn contact
Jacqueline Müller-Nordhorn principal investigator
Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
Martin Tauscher principal investigator
Bavarian Association of Statutory Health Insurance Accredited Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Neoplasm of Lung and Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder), run by Bavarian Cancer Registry at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sven Voigtländer (+49-(0)9131-6808 ext. 2927, sven.voigtlaender@lgl.bayern.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assured NEN diagnosis of the BPS (time frame: 2021-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06282016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.